The present invention relates to an alignment device and method for facilitating alignment of a medical instrument with the tubal ostium of the Fallopian tubes. More particularly, the alignment device includes an expandable member, either in the form of a balloon member or sponge member, which is expandable from a contracted state to an expanded state by a fluid. In addition, the alignment device includes a catheter member attached to the expandable member and also includes, guiding means, in the form of passageways or the like, for guiding a medical instrument through the expandable member.
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1. An alignment device adapted to deliver a medical instrument to an operating site within a body cavity, comprising a catheter member having a proximal end and a distal end, said catheter member including an elongated body having a plurality of channels extending from said proximal end to said distal end, at least one of said channels being sized and shaped so as to allow a medical instrument to pass therethrough and at least another of said channels being sized and shaped so as to allow a fluid to pass therethrough; an expandable member having at least one entrance portal attached to said distal end of said catheter, said expandable member also having a plurality of openings remote from said entrance portal and including a first opening and a second opening, said expandable member being expandable from a contracted state to an expanded state when a fluid is supplied thereto; and guiding means entering said expandable member through said at least one entrance portal for guiding a medical instrument through said expandable member when said expandable member is in its said expanded state, said guiding means including a plurality of tube members extending through said expandable member, said plurality of tube members including a first tube member communicating with the environment external to the alignment device through said first opening and a second tube member communicating with the environment external to the alignment device through said second opening.
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The present invention relates to a device and method for facilitating alignment of a medical instrument within the tubal ostia of the Fallopian tubes. As used herein, the term "medical instrument" includes a medical or surgical instrument.
There are various medical procedures that require doctors and surgeons to gain access to the Fallopian tubes by way of the transcervical, transvaginal access route into the uterus. Such medical procedures include patency testing of the Fallopian tubes, sterilization by tubal ligation or tubal occlusion, and fertilization procedures involving delivery of sperm into the Fallopian tubes. At the present time, several transcervical techniques are being developed to perform voluntary sterilization procedures by tubal occlusion using RF (radio frequency), microwave, implanted materials and chemical means. These transcervical sterilization techniques will replace surgical methods of sterilization, thereby allowing sterilizations to be performed more conveniently in doctors' offices or clinics, rather than in hospitals. These transcervical techniques, however, do not include a means by which their respective medical instruments can be aligned with the tubal ostium to facilitate a successful procedure.
To successfully perform the aforesaid medical procedures, doctors and surgeons must be able to guide the necessary instruments through the vagina and cervix, into the uterus and to the tubal ostium, i.e., the intrauterine opening of the Fallopian tubes. The diameter of each Fallopian tube at the tubal ostium is typically less than 1.0 millimeter. Thus, the most difficult part of the aforesaid medical procedures is often aligning an instrument with the tubal ostium such that the instrument will properly enter the Fallopian tube. Alternatively, proper alignment with the tubal ostium is important in certain procedures to ensure that dye, medicine or sperm will be properly delivered directly into the Fallopian tube, minimizing waste and maximizing the effectiveness of the procedure. Moreover, if such an insertion is attempted and fails, the Fallopian tube will often go into spasm and make subsequent attempts at entry much more difficult. It is, therefore, important that entry into the Fallopian tube during these medical procedures is successful on the first attempt, which, in turn, requires proper alignment with the tubal ostium.
Various methods exist to facilitate the alignment of medical instruments with the tubal ostium. For example, one method involves the transvaginal, transcervical insertion of a hysteroscope into the uterus to allow the doctor to visually align the medical instruments with the tubal ostium. This method, however, requires additional visualization equipment that is expensive and, in many Third World countries, prohibitively expensive. In addition, this method requires training and a skill level that many gynecologists may not possess.
Alignment devices, fluid dispensing instruments, uterine access catheter systems and the like are known for use within the female reproductive system. For example, U.S. Pat. No. 6,080,129 to Blaisdell discloses a catheter system for the uterus having a sleeve slidably disposed over an inner catheter. Initial access to the uterus is accomplished by positioning the inner catheter through the cervix with the sleeve remaining outside of the cervix. After inflating a balloon near the distal end of the inner catheter, contact media can be injected and hysterosalpinogography is performed.
U.S. Pat. No. 4,182,328 to Bolduc et al. discloses a fluid dispensing instrument for placing a drug material into the canals of the Fallopian tubes of a female. The instrument includes a housing carrying a piston and cylinder assembly which is operable to expand a balloon at its distal end, as well as to dispense drugs into the uterine cavity above the partly expanded balloon. The instrument is fully expanded to move the drugs from the uterine cavity into the canals of the Fallopian tubes.
In view of the foregoing, it is an object of the present invention to provide an alignment device for use by medical practitioners in blind medical procedures wherein the medical instrument is aligned with the tubal ostium of each Fallopian tube to facilitate a successful medical procedure within the Fallopian tubes without the use of an hysteroscopic instrument. Such an alignment device lends itself to use by medical personnel who need not have a high level of proficiency.
Another object of the present invention is to provide an alignment device that allows easy access of appropriate medical instruments to both right and left tubal ostium for the bilateral access, evaluation and/or treatment of each Fallopian tube.
Another object of the present invention is to provide an alignment device that eliminates the use of current visualization techniques using expensive hysteroscopic hardware and procedures by the gynecologists to evaluate a reproductive problem of a female patient.
Another object of the present invention is to provide an alignment device that will assist in transcervical sterilization (tubal ligation of the Fallopian tubes through the cervix and vagina) in order to assure accurate entry into the Fallopian tubes via the tubal ostia or tubal ostium.
Another object of the present invention is to provide an alignment device that will allow tubal patency testing to be done in a doctor's office without fluoroscopic procedures that irradiate the female patient and are normally performed in hospital settings.
Another object of the present invention is to provide an alignment device for use in Third World countries where fluoroscopic equipment and hysteroscopic visualization hardware may not be available.
Another object of the present invention is to provide an alignment device that will permit gynecologists, medical practitioners or trained clinic personnel to access the tubal ostia of the Fallopian tubes.
Another further object of the present invention is to provide an alignment device that is easy to use and is fully disposable after use.
A still further object of the present invention is to provide an alignment device that can be mass produced in an automated and economical manner and is readily affordable by the medical practitioner.
In accordance with the present invention, there is provided an alignment device adapted to deliver a medical instrument to an operating site within a body cavity. The alignment device includes a catheter member having an elongated body which is provided with a plurality of channels, at least one of the channels being sized and shaped so as to allow a medical instrument to pass through and at least another of the channels being sized and shaped so as to allow fluid to pass therethrough. The alignment device is also provided with an expandable member, which is expandable from a contracted state to an expanded state by fluid received from the catheter member. Guiding means, in the form of conduits, passageways, or the like, are located within the expandable member for guiding a medical instrument through the expandable member, when it is in its expanded state, to an operating site within a body cavity.
Further objects, features and advantages of the present invention will become apparent upon the consideration of the following detailed description of the various exemplary embodiments considered in conjunction with the accompanying drawings, in which:
With reference to
The female reproductive system 12 includes an elongated vaginal orifice 14, a cervix 16 having a cervical canal 18; an uterus 20 having an uterine cavity 22; tubal ostia 24, 26, and Fallopian tubes 28, 30. The Fallopian tubes 28, 30 are connected to the tubal ostia 24, 26, respectively, and include passageways which exit therefrom. The uterine cavity 22 is joined to the Fallopian tubes 28, 30 via their respective tubal ostia 24, 26, which can be enlarged and elongated as shown in FIG. 10. The cervical canal 18 is located between the lower part of the cervical cavity 18 and the upper end of the elongated vaginal orifice 14, and provides a passageway therebetween. As shown in
The uterus 20 is a generally inverted pear-shaped, thick walled, hollow organ, which varies in size and shape, wall thickness, wall strength, and sensitivity to pain. The uterine cavity 22 is generally flat and triangularly-shaped, but other sizes and shapes can exist. Like the uterus 20, the size and shape of the uterine cavity 22 can also vary. The uterine cavity 22 includes a plurality of cavity walls in the form of a top wall (hereinafter referred to as a fundus 32f) and side walls 32s.
The cervix 16 includes muscles which vary in size and strength such that the insertion of the alignment device 10 through the cervical canal 18 may encounter some resistance. In such cases of cervical canal 18 resistance, a dilator (a surgical instrument or drug that produces dilation of the cervical canal 18) is typically used to open the cervical canal 18 to an opening size of approximately 6 mm in diameter prior to the insertion of the alignment device 10 therein.
With reference to
The catheter 40 is made from a material, such as stainless steel, teflon or silicone, having a range of stiffness from rigid to flexible, and has a length in a range of from about 120 mm to about 140 mm and a diameter in a range of from about 4 mm to about 8 mm. As shown in
With reference to
When inflated as shown in
The second tube member 80, like the first tube member 78, includes a distal end 92, relative to the catheter 40, which has an opening 94. In addition, the second tube member 80 includes a proximal end 96, relative to the catheter 40, which has an opening 98. A passageway 100 extends through the second tube member 80 from the distal end 92 to the proximal end 96. The passageway 100 is sized and shaped to allow a medical instrument to pass therethrough.
The balloon member 42 has an opening 102 sized and shaped to allow the distal end 82 of the first tube member 78 to extend therethrough, an opening 104 sized and shaped to allow the distal end 92 of the second tube member 80 to extend therethrough, and an opening 106 sized and shaped to allow the distal end 46 of the catheter 40 to be received therein. As shown in
The left and right positioning tabs 52a, 52b (see
As shown in
The proximal ends 86, 96 of the tube members 78, 80 are received and cooperate with the passageways 54a, 54b (FIG. 4), respectively, in the catheter 40 (FIG. 1). Further, the proximal ends 86, 96 of the tube members 78, 80 are adjacent and connected to each other.
The opening 106 of the balloon member 42 is attached and connected to the distal end 46 of the catheter 40, as shown in FIG. 5. Also, the tube members 78, 80 are aligned in a planar relationship with each other and their respective distal ends 82, 92 being arranged approximately 180 degrees apart.
When inflated, the balloon member 42 is sized and shaped such that the tube openings 84, 94 align with, and are adjacent to, the tubal ostia 24, 26 (see FIG. 11), respectively. The balloon member 42 can be made from a material which is selected from a group including silicone, latex, urethane, and other flexible polymers. When fully inflated with air, the balloon member 42 has a width in a range of from about 30 mm to about 40 mm, a height in a range of from about 50 mm to about 70 mm, a depth in a range of from about 10 mm to about 15 mm, and a pressure in a range of from about 150 mm Hg to about 250 mm Hg, as determined by the air line 62 (
Each tube member 78, 80 (see
Operation of the Present Invention
With reference to
As shown in
The balloon member 42 is then fully inflated with air, via the air line 62 (see
With the alignment device 10 in place, a medical practitioner 109 (a hand thereof being shown in
Thereafter, the medical instrument 58 enters a corresponding one of the tubal ostia 24, 26 to complete the treatment. After the treatment is completed, the medical instrument 58 is removed from the catheter 40 in the opposite order as previously described. Then, the balloon member 42 of the alignment device 10 is removed from the reproductive system 12 by initially collapsing it via vacuum, via the vacuum line 70, through the passageway 68 (see FIG. 4). Lastly, the alignment device 10 is removed from the uterine cavity 22, the cervical canal 18, and the vaginal orifice 14 and can be medically disposed with in accordance to standard medical protocols.
Description of the Alternate Embodiments
A second exemplary embodiment of the present invention is illustrated in FIG. 6. Elements illustrated in
A third exemplary embodiment of the present invention is illustrated in FIG. 7. Elements illustrated in
The operation of the alignment device 210 is similar and operates in the same manner as the alignment device 10. However, the alignment device 210 is expanded in a different manner than the alignment device 10. That is, the sponge member 211 expands in response to the absorption of liquid by the sponge body 215.
A fourth exemplary embodiment of the present invention is illustrated in FIG. 8. Elements illustrated in
As illustrated in
The tube-catheter member 311 can be made from a polymer material which is selected from a group including nylon, teflon, polyethylene, silicone, tygon, and other flexible polymers. The catheter section 313 has a diameter in a range of from about 4 mm to about 8 mm and a length in a range of from about 150 mm to about 250 mm. When collapsed, the balloon member (not shown) has a length in a range of from about 50 mm to about 60 mm.
It should be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention as defined in the appended claims. Accordingly, all such variations and modifications are intended to be included within the scope of the invention as defined in the appended claims.
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